Insurers back away from controversial 'easy' surgery for uterine fibroids

Saturday

Aug 9, 2014 at 6:00 AMAug 9, 2014 at 10:40 PM

By Geraldine A. Collier CORRESPONDENT

Some might call it a medical tsunami, a controversy that threatens to eliminate certain surgical options for uterine fibroids, a problem that affects hundreds of thousands of women each year.

And the debate, which weighs the benefits for many women against deadly outcomes for some, has sent Massachusetts insurers and HMOs backing away from previous coverage of a minimally invasive technique, while surgeons look for alternatives.

Most women will develop non-cancerous uterine fibroids some time in their lives. Many won't suffer any ill effects, but others will need surgery to remove fibroids that are causing heavy bleeding, pain, difficult sexual intercourse and/or urinary problems.

In the past couple of decades, the most highly skilled gynecological surgeons have been able to offer women a choice between having abdominal surgery that requires a large, open incision; or a minimally invasive procedure, with tiny stitches.

"Doing these big surgeries through little incisions is one of the greatest advances in our field," said Dr. Leslie S. Bradford, an obstetrical/gynecological physician specializing in gynecological oncology at UMass Memorial Medical Center. "Patients recover faster, they stay in the hospital for less time — sometimes going home the same day — there is less blood loss and they (the procedures) are very safe."

But, as it turns out, the minimally invasive surgery is not safe for every woman because of its very nature — those tiny incisions.

"If you have a fibroid that is 10 centimers in size, and you have an incision that is 1 centimeter in size, you have to find some way to remove that fibroid," said Dr. Bradford.

That can involve the use of a power morcellator, a tube containing blades that cut up the fibroid or the uterus itself so it can be removed through those very small incisions.

However, on April 17, the U.S. Food and Drug Administration issued an advisory "discouraging" the use of the power morcellator because, in the cutting process, it can scatter previously unsuspected cancer cells throughout the abdomen and pelvis.

While this unintended consequence was not unknown in the medical world, it was thought to be extremely rare, often cited by physicians as 1 in 10,000.

However, a recent study, published in The Journal of the American Medical Association, now estimates that one in 350 women who have minimally invasive hysterectomies for the removal of the whole uterus or a myomectomy for removal of fibroids have a uterine sarcoma. Unfortunately, there is no reliable way of diagnosing whether a woman has a uterine sarcoma or not before surgery, only afterward.

"At UMass, all the tissue that has been removed is sent to a pathologist for microscopic examination," said Dr. Michael Flynn, chief of urogynecology and reconstructive pelvic surgery at UMMC.

Within a few days, patients and their surgeons know if cancer had been diagnosed, according to Dr. Flynn. But by then it may be too late.

About 600,000 hysterectomies — one-third of which are for fibroids — are performed each year in the U.S., according to the Centers for Disease Control. About 50,000 are done by surgeons using minimally invasive techniques. Another 65,000 women each year undergo a myomectomy, a minimally invasive procedure that removes the fibroid while preserving the uterus, an option that is usually chosen by women of child-bearing age who want to have a baby in the future.

An FDA advisory panel held hearings in July on the use of power morcellators and has forwarded a recommendation to the FDA. The FDA could stick with its current guidelines, or go further and outright ban the use of the power morcellator in hysterectomies and myomectomies.

Some are not waiting for further news from Washington.

One of the largest medical groups in Central Massachusetts, Reliant Medical Care, stopped doing minimally invasive hysterectomies and myomectomies involving power morcellation after the FDA issued the April advisory, according to a spokesman. The doctors group will not consider resuming its use until a full assessment of its safety has been conducted.

Currently, Reliant patients — as well as patients elsewhere — are being offered hysterectomies that involve the removal of the uterus through the vagina or a large abdominal incision, and myomectomies, where the fibroid is also removed through a large abdominal incision.

Over at UMass Memorial, Dr. Bradford said she would present a patient with all options so that she could make an informed decision.

"I see informed consent as an opportunity to respect a patient's autonomy, present a patient with all of the options and to guide her in the decision-making process," she said. "If a patient can't live with the thought of morcellation, then I think it's reasonable to perform an 'open' surgery.

"Likewise, a patient may hear about the risks of potential cancer, decide that the benefits of a minimally invasive approach outweigh the incredibly small risk of cancer, and move forward with a minimally invasive surgery that may include morcellation," Dr. Bradford said.

The 80 hospitals owned by Tenet Healthcare, including St. Vincent Hospital in Worcester, stopped using power morcellation in hysterectomies or myomectomies as of Aug. 7, according to Ellen Beth Levitt, director of communications for the chain.

Decisions made by surgeons or hospitals or, for that matter, patients, are almost moot at this point, as insurers are quickly backing away from coverage of the use of power morcellators. One major manufacturer of these devices, Johnson & Johnson, has issued a recall of its product.

Blue Cross-Blue Shield of Massachusetts, following the guidelines contained in the April FDA advisory, will no longer cover hysterectomies or myometomies using power morcellation as of Sept. 1.

"Harvard Pilgrim will follow the FDA guidance concerning the use of power morcellators for hysterectomies and myomectomies," said Mary Wallan, a spokeswoman for that insurer. "However, in rare instances of an individual's patient's medical necessity, coverage of this device would be considered," said Ms. Wallan.

"Our coverage decision is consistent with currently available medical evidence and data as well as the recent warnings issued by the FDA regarding the use of power morcellation in minimally invasive surgery for uterine fibroids," she said.

However, Tufts Health Plan is still covering the use of the morcellator in minimally invasive hysterectomies and myomectomies.

"We rely on the physician to make treatment decisions based on the specific clinical presentation of the patient and current literature," said Sonya Hagopian, vice president for corporate communications and public relations at Tufts Health Plan.